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| Name | Class |
|---|---|
| Imalux | UNKNOWN |
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Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine cervix can differentiate between grades of pre-invasive and invasive cervical disease and cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to detect pre-invasive cervical disease and cervical cancer.
B. Specific Aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niris 1300e OCT imaging | Experimental | OCT imaging of the cervix using Niris 1300e will include computer aided calculations for epithelial brightness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRIS 1300e | Device | Optical coherence tomography (OCT) is similar to ultrasound pulse-echo imaging, with optical scatter rather than acoustic reflectivity being measured. OCT employs harmless near-infrared light technology which uses low coherence interferometry to produce an image (based on optical scattering) of tissue microstructure. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination. | Study will be completed over a 4 day period with OCT and brightness determination as each patient is seen. During the next 4 months, we will conduct blinded reviews of the images to determine new sets of brightness numbers. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare OCT image (Niris 1300e) technology directly to colposcopy with biopsy for the detection of lesions equal or greater than cervical intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation. | Study will be completed over a 4 day period with OCT and brightness determination as each patient is seen. During the next 4 months we will conduct blinded reviews of the images to determine new sets of brightness numbers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome L Belinson, MD | Preventive Oncology International | Principal Investigator |
| Rufiang Wu, MD | Peking University Shenzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20375808 | Background | Wulan N, Rasool N, Belinson SE, Wang C, Rong X, Zhang W, Zhu Y, Yang B, Tresser NJ, Mohr M, Wu R, Belinson JL. Study of the diagnostic efficacy of real-time optical coherence tomography as an adjunct to unaided visual inspection with acetic acid for the diagnosis of preinvasive and invasive neoplasia of the uterine cervix. Int J Gynecol Cancer. 2010 Apr;20(3):422-7. doi: 10.1111/IGC.0b013e3181d09fbb. | |
| 20134271 |
| Label | URL |
|---|---|
| Preventive Oncology International, Inc. | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 16, 2014 | |
| Reset | May 15, 2014 | |
| Release | May 19, 2014 |
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|
| Background |
| Liu Z, Belinson SE, Li J, Yang B, Wulan N, Tresser NJ, Wang C, Mohr M, Zhang L, Zhou Y, Weng L, Wu R, Belinson JL. Diagnostic efficacy of real-time optical coherence tomography in the management of preinvasive and invasive neoplasia of the uterine cervix. Int J Gynecol Cancer. 2010 Feb;20(2):283-7. doi: 10.1111/IGC.0b013e3181cd1810. |
| 23343696 | Background | Belinson SE, Ledford K, Rasool N, Rollins A, Wilan N, Wang C, Rong X, Zhang W, Zhu Y, Tresser N, Wu R, Belinson JL. Cervical epithelial brightness by optical coherence tomography can determine histological grades of cervical neoplasia. J Low Genit Tract Dis. 2013 Apr;17(2):160-6. doi: 10.1097/LGT.0b013e31825d7bf0. |
| Reset | Jun 19, 2014 |
| Release | Jun 26, 2014 |
| Reset | Jul 24, 2014 |
| Release | Aug 12, 2014 |
| Reset | Aug 26, 2014 |
| Release | Nov 6, 2014 |
| Reset | Nov 14, 2014 |
| Release | Nov 18, 2014 |
| Reset | Nov 24, 2014 |
| Release | Nov 26, 2014 |
| Reset | Nov 28, 2014 |
| Release | May 6, 2015 |
| Reset | May 20, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2014 | May 15, 2014 | |||
| May 19, 2014 | Jun 19, 2014 | |||
| Jun 26, 2014 | Jul 24, 2014 | |||
| Aug 12, 2014 | Aug 26, 2014 | |||
| Nov 6, 2014 | Nov 14, 2014 | |||
| Nov 18, 2014 | Nov 24, 2014 | |||
| Nov 26, 2014 | Nov 28, 2014 | |||
| May 6, 2015 | May 20, 2015 |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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